Modular antitachyarrhythmia therapy system

ABSTRACT

This document discusses, among other things, a modular antitachyarrhythmia therapy system. In an example, a modular antitachyarrhythmia system includes at least two separate modules that coordinate delivery an antitachyarrhythmia therapy, such as defibrillation therapy. In another example, a modular antitachyarrhythmia therapy system includes a sensing module, an analysis module, and a therapy module.

CLAIM OF PRIORITY

This application is a continuation of U.S. patent application Ser. No.14/510,626, entitled “MODULAR ANTITACHYARRHYTHMIA THERAPY SYSTEM,” filedOct. 9, 2014; which is a divisional of Smith, et al., U.S. patentapplication Ser. No. 14/164,447, entitled “MODULAR ANTITACHYARRHYTHMIATHERAPY SYSTEM,” filed on Jan. 27, 2014; which is a continuation of andclaims the benefit of priority under 35 U.S.C. §120 to Smith et al.,U.S. patent application Ser. No. 13/662,882, entitled “MODULARANTITACHYARRHYTHMIA THERAPY SYSTEM,” filed on Oct. 29, 2012, now U.S.Pat. No. 8,649,859; which is a continuation of Smith et al., U.S. patentapplication Ser. No. 11/131,583, entitled “MODULAR ANTITACHYARRHYTHMIATHERAPY SYSTEM,” filed on May 18, 2005, now U.S. Pat. No. 8,391,990;each of which are hereby incorporated by reference herein in itsentirety.

TECHNICAL FIELD

This patent document pertains generally to arrhythmia therapy devicesand methods, and more particularly, but not by way of limitation, tomodular implantable devices that are configured to deliver anantitachyarrhythmia therapy.

BACKGROUND

Implantable arrhythmia therapy devices such as pacers and defibrillatorstypically include a power source such as a battery, an electrode, and acontroller. A lead carrying the electrode typically has a proximal endthat is coupled to a housing that contains the power source andcontroller, and a distal end that is located in, on, or around theheart. A lead can be introduced into a heart chamber, for example.

A pacing lead typically includes at least one electrode that isconfigured to deliver a pacing pulse, and a conductor that couples theelectrode to a signal generator. Some pacing leads also include asensing electrode and a second conductor that couples the sensingelectrode to a sensing circuit.

A defibrillation lead typically includes an anode and a cathode. Forexample, a typical defibrillation lead includes two coils that arecoupled to anode and cathode portions of a battery. A vector is definedbetween the anode and cathode. The effectiveness of a defibrillationtherapy is affected by the configuration of the anode and cathode, andthe vector defined by the anode and cathode.

In some patients, the presence of one or more implanted leads restrictson the patient's range of motion. Moreover, in a growing patient, suchas a child, the patient may outgrow a lead. In some growing patients, itcan be necessary to periodically explant a pacer or defibrillator andreplace the device or implant longer or different leads.

Improved implantable arrhythmia therapy devices are needed.

SUMMARY

In an example, a modular implantable device or system includes animplantable first and an implantable second circuit physically separatefrom the first circuit. The implantable first circuit includes a sensorto sense a physiologic parameter and a wireless transmitter circuit tosend a wireless communication that includes information derived from thephysiologic parameter. The implantable second circuit includes awireless receiver circuit to receive the wireless communication and anantitachyarrhythmia therapy circuit to deliver a responsiveantitachyarrhythmia therapy.

In another example, a modular implantable device or system includes animplantable first circuit, an implantable second circuit, physicallyseparate from the first circuit, and an implantable third circuit,physically separate from the second circuit. The implantable firstcircuit includes a sensor to sense a physiologic parameter, and acommunication or driver circuit to send a communication that includesinformation about the physiologic parameter. The implantable secondcircuit includes a receiver circuit to receive the communication fromthe first implantable circuit, a controller circuit to analyze theinformation about the physiologic parameter, and a wireless transmittercircuit to send a wireless therapy instruction. The implantable thirdcircuit includes a wireless receiver to receive the wireless therapyinstruction, and an antitachyarrhythmia therapy circuit to deliver anantitachyarrhythmia therapy.

In another example, a modular implantable device includes an implantablefirst defibrillation circuit module configured to deliver a firstdefibrillation shock, an implantable second defibrillation circuitmodule, physically separate from the first defibrillation circuitmodule, configured to deliver a second defibrillation shock concurrentwith the first defibrillation shock, and a controller circuit configuredto direct coordinated delivery of the first and second defibrillationshocks.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsdescribe substantially similar components throughout the several views.The drawings illustrate generally, by way of example, but not by way oflimitation, various embodiments discussed in the present document.

FIG. 1A is an illustration of a modular antitachyarrhythmia system thatincludes two antitachyarrhythmia therapy modules.

FIG. 1B is a schematic illustration of the system shown in FIG. 1A.

FIG. 2A is an illustration of a modular antitachyarrhythmia system thatincludes a sensing module, an analysis module, and a therapy module.

FIG. 2B is a schematic illustration of the system shown in FIG. 2A.

FIG. 3A is an illustration of a modular antitachyarrhythmia system thatincludes a sensing module, an analysis module, and a two therapymodules.

FIG. 3B is a schematic illustration of the system shown in FIG. 3A.

FIG. 4A is an illustration of a modular antitachyarrhythmia system thatincludes a sensing module and two antitachyarrhythmia therapy modules.

FIG. 4B is a schematic illustration of the system shown in FIG. 4A.

FIG. 5A is an illustration of a modular antitachyarrhythmia system thatincludes a therapy module and two sensing/analysis modules.

FIG. 5B is a schematic illustration of the system shown in FIG. 5A.

FIG. 6A is an illustration of a modular antitachyarrhythmia system thatincludes a sensing/therapy module and an analysis module.

FIG. 6B is a schematic illustration of the system shown in FIG. 6A.

FIG. 7A is an illustration of a modular antitachyarrhythmia system thatincludes a sensing module and an analysis/therapy module.

FIG. 7B is a schematic illustration of the system shown in FIG. 7A.

FIG. 8A is an illustration of a system that includes a plurality ofsensing modules.

FIG. 8B is a schematic illustration of the system shown in FIG. 8A.

FIG. 9 is a schematic illustration of an embodiment of anantitachyarrhythmia therapy circuit.

DETAILED DESCRIPTION Overview

An antitachyarrhythmia system, such as a defibrillation system, includesat least two physically separate modules that communicate with eachother through a wireless communication. Numerous example systems areshown in FIGS. 1A to 8B. A module is a component that is used with othercomponents, from which it is physically separate when implanted in thebody. For example, in FIG. 1A, module 105 is used with module 110 and isphysically separate from module 110.

Examples of wireless communication techniques include a radio frequency(RF) signal, inductive coupling, or conduction through the body.Wireless communications between modules include, for example,information about or derived from a physiologic parameter detected by asensor, or one or more instructions to deliver, schedule, synchronize,or coordinate delivery of an antitachyarrhythmia therapy. In oneexample, wireless communication between modules avoids or reduces theuse of leads. In some examples, all of the modules are physicallydisjoint, i.e. there are not physical connections between them. FIGS.1A-4A show examples of physically disjoint modules. In other examples,some of the modules are physically disjoint, and others are connected.For example, the systems shown in FIGS. 5A and 6A include at least oneleadless module and at least one module coupled to a lead.

In an example, a modular antitachyarrhythmia system permits growth of apatient. For example, a system implanted in a child can expand as achild grows, i.e. the modules can still operate as they become fartherapart as the child grows because the modules are not tied together withleads. In another example, a modular antitachyarrhythmia system providesfree range of motion to a patient.

Modular antitachyarrhythmia systems, such as the systems shown in FIGS.1A-8B, can be used in one or more of a variety of applications. In oneexample, unique flux fields are created by strategically positioningmodules containing electrodes. For example, defibrillation vectors canbe tailored by carefully positioning modules. The example illustrated inFIG. 1A shows two separate defibrillation modules implanted near theheart. FIG. 2A shows two separate defibrillation modules implanted inthe heart. In some examples, leadless modules with electrodes areimplantable in locations that would be practically impossible usingtethered systems, such as certain portions of the peripheralvasculature. In an example, a module is sized and shaped forimplantation in the pulmonary vasculature, such as in the pulmonaryvasculature bed, or in the renal vasculature. In an example, one or moremodules is implanted subcutaneously or submuscularly. In an example, amodule is sized and shaped for implantation in the intraclavicle spaceinferior to the clavicle. In another example, a module is sized andshaped for implantation on or around the solar plexus. In anotherexample, a module is sized and shaped for submuscular, intramuscular,intracardiac, or intravascular implantation. In an example, anintravascular or intracardiac module avoids occluding a blood vessel orinterfering with valve heart valves.

In an example, modules are implanted in locations that allow fornear-field sensing of an intrinsic electrical heart signal. In oneexample, separate modules are positioned in or around specific locationsof the heart or peripheral vasculature so that local intrinsic signalscan be sensed at specific locations. In an example, a module is sizedand shaped for implantation in a right ventricular apex. In an example,a module is sized and shaped for endocardial implantation, for examplein a right atrium or right ventricle. In an example, a module is sizedand shaped for implantation in a right atrial appendage. In an example,a module is sized and shaped for implantation in the coronary sinus, invessels extending from the coronary sinus, or in other venousvasculature. In an example, a module is sized and shaped forimplantation on an epicardial surface, such as on a left atrium or leftventricle epicardial surface.

In other examples, a module that is depleted or dysfunctional isreplaced, while one or more other modules are left intact. In oneexample, a module implanted in the heart is left in place, while amodule implanted outside the heart is replaced or upgraded. Asubcutaneously implanted module, for example, is replaceable with arelatively noninvasive procedure.

Some examples of a modular antitachyarrhythmia system can also bechanged over time as needed by replacing or adding one or more modules.For example, analysis or therapy programming circuits can be replaced orupgraded. In another example, pacing capability can be added by adding apacing module. Modules can be added as a disease progresses or changes.

In another example, a modular antitachyarrhythmia therapy system isimplanted in a growing patient, such as a child. In an example,dissemination of the total volume of the modular system over more thanone anatomic location enables local organ growth and overall body growthwithout compromising the functionality of the system. In an example, thereduction or elimination of leads enables organ growth or overall bodygrowth, as the distance between components is allowed to change as thepatient grows.

In an example implant method, the components of a system are implantedat predetermined anatomical locations in a patient. In an example, thecomponents are then tested using a standardized protocol. In an example,the standardized protocol is integrated into an external programmer orother adjunct device.

Examples of Modular Antitachyarrhythmia Systems

FIG. 1 is an example of a modular antitachyarrhythmia therapy system100. In one example, the antitachyarrhythmia system 100 includes twoseparate antitachyarrhythmia therapy modules 105, 110 that cooperate todeliver a coordinated therapy. Module 105 includes two electrodes 106,107 and module 110 includes two electrodes 111, 112. In an example, themodules 105, 106 each include a hermetically sealed electronics unit. Inan example, the hermetically sealed electronics unit includes a housingand a header, and the electrodes 106, 107, 111, 112 are located on thehousing, on the header, or are contained in a lead that is coupled to amodule header. In an example, module 105 delivers an antitachyarrhythmiatherapy from electrode 106 through a portion of the heart 101 toelectrode 107, and module 110 delivers an antitachyarrhythmia therapyfrom electrode 111 through a portion of the heart 101 to electrode 112.In an example, the modules communicate with each other through wirelesscommunication. In an example, the modules 105, 110 coordinate orsynchronize an antitachyarrhythmia therapy through the wirelesscommunication.

In an example, one or both of the modules 105, 110 are implanted in theheart. In another example, one or both of the modules is implanted inthe body but outside of the heart. In an example, at least one of themodules is sized and shaped for implantation in a peripheral cardiacvessel, such as the coronary sinus. In an example, a module includes afixation helix that connects the module to heart tissue.

In an example, a module is sized and shaped to be wedged into a vessel,such as in renal vasculature or pulmonary vasculature. In an example, amodule is sized and shaped to be wedged into a vessel having a diameterthat decreases in diameter along the length of the vessel, and wedgingthe module into the vessel fixes the module in place. In an example, themodule occludes a portion of venous vasculature.

In another example, a module is sized and shaped for implantation incoronary vasculature, such as in the coronary sinus. In an example, themodule is driven in place using a lead.

In an example, the modules 105, 110 shown in FIG. 1A are both fullyfunctional defibrillators, i.e. both modules includes sensing, analysis,and therapy circuitry. In another example, the modules operate in amaster/slave relationship. In one example, module 105 operates as amaster and includes analysis circuitry that directs delivery of anantitachyarrhythmia therapy through electrodes 111, 112, in module 110.

FIG. 1B shows a schematic illustration of one example of the systemillustrated in FIG. 1A. In this example, module 105 includes sensecircuit 115, controller circuit 120, antitachyarrhythmia therapy circuit125, and communication circuit 130. In an example, the communicationcircuit 130 includes telemetry circuitry, such as an RF or inductivetransceiver. In another example, the communication circuit uses a humanor animal body as a conductive medium for a wireless communication.Sense circuit 115 detects one or more physiological parameters, such ascardiac performance data. In an example, sense circuit 115 includes asense amplification circuit to detect at least one intrinsic electricalheart signal. Controller circuit 120 analyzes physiological datadetected by the sense circuit 115, determines whether a tachyarrhythmiais present, and determines at least one responsive antitachyarrhythmiatherapy, such as a defibrillation shock therapy or antitachyarrhythmiapacing therapy. Antitachyarrhythmia therapy circuit 125 delivers theantitachyarrhythmia therapy determined by the controller circuit 120.Antitachyarrhythmia circuit 125 includes the electrodes 106, 107 shownin FIG. 1A. In an example, the antitachyarrhythmia circuit includes apulse generator coupled to the electrodes, as shown in FIG. 9A. In anexample, the pulse generator includes a battery, a capacitor, andcircuitry for charging the capacitor and delivering a defibrillationtherapy.

In an example, module 110 is a second fully function defibrillator thatincludes a sense circuit 135, a controller circuit 140, anantitachyarrhythmia therapy circuit 145, and a communication circuit150. Controller circuit 140 analyzes physiological data detected by thesense circuit 135, determines whether a tachyarrhythmia is present, anddetermines at least one responsive antitachyarrhythmia therapy, which isdelivered through the antitachyarrhythmia circuit 145. The modules 105,110 communicate with each other through the communication circuits 130,150, such as to coordinate, schedule, or synchronize therapy.

In an example master/slave system, one of the modules 105, 110 alsodetermines a therapy to be delivered through one of the modules 105,110. In an example, module 110 operates as a slave module. In oneexample, module 110 does not include an analysis circuit. In thisexample, controller circuit 120 of module 105 determines a therapy basedupon data received from sense circuit 135 and directs theantitachyarrhythmia therapy circuit 145 in the other module 110 todeliver a responsive therapy. In another example, module 110 includesneither a sense circuit nor an analysis circuit, and a therapy isdetermined from data provided by sense circuit 115 in module 105. Inanother example, module 110 includes an analysis circuit, but module 105determines an appropriate antitachyarrhythmia therapy and directsdelivery of the therapy through module 110.

In an example, a pacing circuit is also provided in one or both of theantitachyarrhythmia modules. In another example, a physically separatepacing module including pacing circuitry and communication circuitry isprovided, with the separate pacing module configured for communicationwith one or both of the modules 105, 110.

In an example, a therapy for a patient is tailored by strategicallypositioning the antitachyarrhythmia modules 105, 110 in anatomicallocations to obtained desired vectors. In an example, the modules areimplanted outside the heart, as shown in FIG. 1A. Alternatively, one orboth modules are implanted in the heart. In an example, the modules 105,110 are implantable in a location that can be difficult to reach with anelectrode tethered to a lead. In an example, one of the modules 105, 110is implanted in or on the left side of the heart 101. In an example, amodule is sized and shaped for implantation in the coronary sinus, in avessel extending from the coronary sinus, or on an epicardial orpericardial surface. In an example, a module is affixed using a T-barand a modified suture technique. In an example, the T-bar has an openingthrough which a needle is inserted.

The left side of the heart is relatively difficult to reach with anendocardial defibrillation lead because of the complex vasculaturethrough which such a lead would be inserted to reach the left side ofthe heart. In an example, implantation of a module avoids occlusion of ablood vessel or interference with a heart valve.

Another example of a modular antitachyarrhythmia therapy system is shownin FIG. 2A. The example antitachyarrhythmia system 200 includes threeseparate modules 205, 210, 215 that respectively perform therapy,sensing, and analysis. Sensing module 210 includes a sensor that detectsat least one physiologic parameter, such as an intrinsic electricalheart signal or blood pressure. In another example, sensing module 210is implanted on or around the heart. Analysis module 215 wirelesslyreceives information from sensing module 210 and processes theinformation to determine whether a tachyarrhythmia is present anddetermine an appropriate antitachyarrhythmia therapy. Analysis module215 directs therapy module 205 to deliver an antitachyarrhythmia therapythrough electrodes 206, 207. In an example, therapy module 205 deliversan antitachyarrhythmia therapy from electrode 206 through a portion ofthe heart 201 to electrode 207.

FIG. 2B shows a schematic illustration of the system illustrated in FIG.2A. In this example, sensing module 210 includes sensor circuit 230,which detects one or more physiological parameters, such as an intrinsicelectrical heart signal. Sensing module 210 also includes acommunication circuit 235 that wirelessly sends information about theone or more sensed parameters to the analysis module 215. In oneexample, the communication circuit 235 includes telemetry circuitry,such as an inductive or RF transmitter or transceiver. Analysis module215 includes controller circuit 240 and a communication circuit 245 thatreceives information sent by the communication circuit 235 in thesensing module 210. Controller circuit 240 analyzes physiological dataprovided by the sensing module 210 and determines whether anantitachyarrhythmia is present and, if so, determines an appropriateantitachyarrhythmia therapy, such as a defibrillation shock therapy orantitachyarrhythmia pacing (ATP) therapy. The communication circuit 245also includes a wireless transmitter, through which a direction is sentto the antitachyarrhythmia therapy module 205 to deliver theantitachyarrhythmia therapy. Antitachyarrhythmia therapy module 205includes a communication circuit 225 including a wireless receiver thatreceives the communication from the communication circuit 245 in theanalysis module 215. Antitachyarrhythmia therapy module 205 alsoincludes an antitachyarrhythmia therapy circuit 220, which includes oris coupled to the electrodes 206, 207 shown in FIG. 2A. Theantitachyarrhythmia therapy circuit 220 delivers the antitachyarrhythmiatherapy determined by the controller circuit 240 through the electrodes206, 207.

In an example, a pacing circuit is also provided in theantitachyarrhythmia module 205, the sensing module 210, or the analysismodule 215. In another example, the system includes a separate pacingmodule including pacing circuitry and communication circuitry.

In an example, a therapy for a patient is obtained by strategicallypositioning the antitachyarrhythmia therapy module 205 in a particularanatomical location. In an example, the antitachyarrhythmia therapymodule 205 is implanted in the heart, as shown in FIG. 2A. In anexample, the antitachyarrhythmia therapy module 205 is implanted in theright ventricle. In another example, the module 205 is implantable in oron the left side of the heart. In an example, the sensing module 210 isalso placed in a desired location for sensing one or more parameters,such as an intrinsic electrical heart signal. In an example, theanalysis module 215 is implanted subcutaneously, which allows theanalysis module 215 to be replaced or upgraded without requiringreplacement of other separate modules that are implanted deeper in thebody. In another example, the analysis module 215 is implanted near theabdomen, as shown in FIG. 2A. Alternatively, the analysis module 215 isimplanted subcutaneously, such as on the left side of the upper bodynear the heart.

Another example of a modular antitachyarrhythmia therapy system 300 isshown in FIG. 3A. The example antitachyarrhythmia system 300 includes asensing module 320, a separate analysis module 315, and two separateantitachyarrhythmia therapy modules 305, 310 that deliver a coordinatedantitachyarrhythmia therapy. Sensing module 320 includes a sensor thatdetects a physiologic parameter, such as an intrinsic electrical heartsignal or blood pressure. Analysis module 315 receives information fromsensing module 320 and processes the information to determine anantitachyarrhythmia therapy. Analysis module 315 directs therapy modules305, 310 to deliver a coordinated antitachyarrhythmia therapy throughelectrodes 306, 307, 311, 312. In an example, therapy module 305delivers an antitachyarrhythmia therapy from electrode 306 through aportion of the heart 301 to electrode 307, and therapy module 310delivers an antitachyarrhythmia therapy from electrode 311 through aportion of the heart 301 to electrode 312.

FIG. 3B shows a schematic illustration of the system illustrated in FIG.3A. Sensing module 320 includes sensor circuit 355, which detects one ormore physiological parameters, such as an intrinsic electrical heartsignal. Sensing module 320 also includes a communication circuit 360that sends information about the one or more sensed parameters to theanalysis module 315. In one example, the communication circuit 360 inthe sensing module 320 includes telemetry circuitry, such as aninductive or RF transmitter. In another example, the communicationcircuit 360 includes an inductive or RF transceiver. Analysis module 315includes controller circuit 345 and communication circuit 350. Thecommunication circuit 350 in the analysis module 315 receivesinformation sent by the communication circuit 360 in the sensing module320. Controller circuit 345 analyzes physiological data provided by thesensing module 320 and determines an antitachyarrhythmia therapy, suchas a defibrillation shock therapy. Antitachyarrhythmia therapy modules305, 310 include respective communication circuits 330, 340 that receivea communication from the communication circuit 350 in the analysismodule 315. Antitachyarrhythmia therapy modules 305, 310 also includerespective antitachyarrhythmia circuits 325, 335, which respectivelyinclude the electrodes 306, 307, 311, 312 shown in FIG. 3A.Antitachyarrhythmia therapy modules 305, 310 deliver theantitachyarrhythmia therapy determined by the controller circuit 345through the electrodes 306, 307, 311, 312. In an example, the analysismodule coordinates delivery of a therapy by the antitachyarrhythmiamodules 305, 310. In another example, the communication circuits 330,340 in the antitachyarrhythmia modules 305, 310 communicate with eachother to coordinate or synchronize an antitachyarrhythmia therapy.

In an example, the analysis module 315 is implanted subcutaneously andcan be replaced or upgraded with a relatively minor procedure withoutaltering or disturbing the other modules in the system. In an example,antitachyarrhythmia therapy module 305 is implanted in the heart andantitachyarrhythmia therapy module 310 is implanted outside the heart.In another example, antitachyarrhythmia therapy module 305 is implantedin the left side of the heart and antitachyarrhythmia therapy module 310is implanted in the right side of the heart. In an example, sensingmodule 320 or other modules are in or on the heart, or in an epicardialspace. In an example, sensing module 320 is implanted in the right sideof the heart.

Another example of a modular antitachyarrhythmia therapy system is shownin FIG. 4A. The example antitachyarrhythmia system 400 includes asensing module 415 and two separate antitachyarrhythmia therapy modules405, 410. Sensing module 415 includes a sensor that detects aphysiologic parameter, such as an intrinsic electrical heart signal orblood pressure. Therapy module 405 includes two electrodes 406, 407 andtherapy module 410 includes two electrodes 411, 412. In an example,therapy module 405 delivers an antitachyarrhythmia therapy fromelectrode 406 through a portion of the heart 401 to electrode 407, andtherapy module 410 delivers an antitachyarrhythmia therapy fromelectrode 411 through a portion of the heart 401 to electrode 412. Themodules 405, 410, 415 communicate wirelessly. In an example, the therapymodules 405, 410 coordinate or synchronize a therapy through thewireless communication.

FIG. 4B shows a schematic illustration of the system illustrated in FIG.4A. Sensing module 415 includes sense circuit 450, which detects one ormore physiological parameters, such as an intrinsic electrical heartsignal. Sensing module 415 also includes a communication circuit 455that sends information about the one or more sensed parameters to theother modules. In one example, the communication circuit 455 includes aninductive or RF transmitter. In another example, the communicationcircuit 455 includes an inductive or RF transceiver. Modules 405, 410include respective controller circuits 420, 435, antitachyarrhythmiatherapy circuits 425, 440 and communication circuits 430, 445. Thecommunication circuits 430, 445 receive information from thecommunication circuit 455 in the sensing module 415. Controller circuits420, 435 analyze physiological data provided by the sense circuit 450and determine an antitachyarrhythmia therapy, such as a defibrillationshock therapy. Antitachyarrhythmia therapy circuits 425, 440 include therespective electrodes 406, 407 and 410, 411. Antitachyarrhythmia therapycircuits 425, 440 deliver an antitachyarrhythmia therapy determined bythe respective controller circuit 420, 435 through the respectiveelectrodes 406, 407 and 410, 411. In an example, antitachyarrhythmiamodules 405, 410 communicate to coordinate or synchronize delivery of anantitachyarrhythmia therapy.

In an example, separate modules 405, 410, 415 are implanted outside theheart. In another example, one or more of the separate modules 405, 410,415 are implanted in the heart.

Another example of a modular antitachyarrhythmia therapy system is shownin FIG. 5A. The example system 500 includes a therapy module 505 and aseparate sensing/analysis module 510 that performs sensing and analysis.Sensing/analysis module 510 includes a sensor 515 that detects aphysiologic parameter and also includes controller circuitry thatreceives information from the sensor 515 and processes the informationto determine whether a tachyarrhythmia is present and, if so, determinesan appropriate antitachyarrhythmia therapy. In an example, thecontroller circuitry is contained in a housing 514 and the sensor 515 isconnected to the housing with a lead 516. Analysis module 510 directstherapy module 505 to deliver an antitachyarrhythmia therapy throughelectrodes 506, 507. In an example, therapy module 505 delivers anantitachyarrhythmia therapy from electrode 506 through a portion of theheart 501 to electrode 507. In an example, antitachyarrhythmia therapymodule 505 is implanted outside the heart as shown in FIG. 5A, such asin the subcutaneously below or between the ribs. In another example,antitachyarrhythmia module 505 is implanted in the heart, such as in theright atrium or right ventricle.

FIG. 5B shows a schematic illustration of the system illustrated in FIG.5A. Sensing/analysis module 510 includes controller circuit 530, sensorcircuit 540, and communication circuit 535. Sensor circuit 540 includesthe sensor 515 that detects one or more physiological parameters.Controller circuit 530 analyzes physiological data provided by thesensor circuit 540 and determines whether a tachyarrhythmia is presentand, if so, determines an appropriate antitachyarrhythmia therapy, suchas a defibrillation shock therapy or antitachyarrhythmia pacing (ATP)therapy. A direction, such as a direction to initiate or adjust theantitachyarrhythmia therapy, is sent to the antitachyarrhythmia therapymodule 505 through the communication circuit 535. In one example, thecommunication circuit 535 includes telemetry circuitry, such as aninductive or RF transmitter. In another example, the communicationcircuit 535 includes an inductive or RF transceiver. Antitachyarrhythmiatherapy module 505 includes a communication circuit 525 that receivesthe communication from the communication circuit 535 in the analysismodule 510. Antitachyarrhythmia therapy module 505 also includes anantitachyarrhythmia therapy circuit 520, which includes the electrodes506, 507 shown in FIG. 5A. Antitachyarrhythmia therapy circuit 520delivers the antitachyarrhythmia therapy determined by the controllercircuit 530 through the electrodes 506, 507.

Another example of a modular antitachyarrhythmia therapy system is shownin FIG. 6A. The example system 600 includes a sensing/therapy module 605and a separate analysis module 615. Sensing/therapy module 605 includesa sensor 610 that detects a physiologic parameter and also includestherapy circuitry that delivers an antitachyarrhythmia therapy. In anexample, sensor 610 is located in the heart. In another example, sensor610 is located outside the heart. In an example, the therapy circuitryis contained in a housing 614 and the sensor 610 is connected to thehousing with a lead 616. The sensing/therapy module 605 communicateswirelessly with an analysis module 615. Analysis module determineswhether a tachyarrhythmia is present and, if so, directs sensing/therapymodule 605 to deliver an appropriate antitachyarrhythmia therapy throughelectrodes 606, 607. In an example, therapy module 605 delivers anantitachyarrhythmia therapy from electrode 606 through a portion of theheart 601 to electrode 607. In an example, the sensing/therapy module605 is implanted outside the heart, as shown in FIG. 6A. In anotherexample, the sensing/therapy module is implanted in the heart.

FIG. 6B shows a schematic illustration of the system illustrated in FIG.6A. Sensing/therapy module 605 includes sense circuit 625,antitachyarrhythmia therapy circuit 620, and communication circuit 630.The antitachyarrhythmia therapy circuit 620 includes the electrodes 606,607 shown in FIG. 6A. Sense circuit 625 includes the sensor 610 thatdetects one or more physiological parameters. Sensing/therapy module 605sends physiological data through communication circuit 630 to theanalysis module. Analysis module 615 includes a controller circuit 635and a communication circuit 640. Communication circuit 640 receives thecommunication from the sensing/analysis module 605. In one example, thecommunication circuits 630, 640 each include an RF transceiver and thecircuits communicate through RF signals. Controller circuit 635 analyzesphysiological data provided by the sense circuit 640 and determines anantitachyarrhythmia therapy, such as a defibrillation shock therapy orATP therapy. Analysis module then sends an antitachyarrhythmia therapyinstruction through the communication circuit 640 to theantitachyarrhythmia therapy module 605. Antitachyarrhythmia therapycircuit 620 delivers the antitachyarrhythmia therapy determined by thecontroller circuit 635 through the electrodes 606, 607.

Another example of a modular antitachyarrhythmia therapy system is shownin FIG. 7A. The example system 700 includes a sensing module 710 and ananalysis/therapy module 705. Sensing module 710 includes a sensor 711that detects a physiologic parameter. The sensing module 710communicates wirelessly with an analysis/therapy module 715.Analysis/therapy module 705 includes controller circuitry that analyzesdata provided by the sensing module 710 and determines whether atachyarrhythmia is present and, if so, determines an appropriateantitachyarrhythmia therapy. Analysis/therapy module 705 also includestherapy circuitry that delivers the antitachyarrhythmia therapy, forexample, to a heart 701.

FIG. 7B shows a schematic illustration of the system illustrated in FIG.7A. Sensing module 710 includes a sense circuit 730 that includes thesensor 711 shown in FIG. 7A. Sensing module 710 also includes acommunication circuit 735 that sends information about sensedphysiologic parameters to the analysis/therapy module 705.Analysis/therapy module 705 includes controller circuit 720,antitachyarrhythmia therapy circuit 715, and communication circuit 725.Communication circuit 725 receives the communication from the sensingmodule 710. In one example, the communication circuits 725, 735 eachinclude telemetry circuitry, and the circuits communicate through RF orinductive signals. Controller circuit 720 analyzes physiological dataprovided by the sense circuit 730 and determines whether atachyarrhythmia is present and, if so, determines an appropriateantitachyarrhythmia therapy, such as a defibrillation shock therapy orATP therapy. The controller circuit 720 then sends anantitachyarrhythmia therapy delivery instruction to theantitachyarrhythmia therapy circuit 715. Antitachyarrhythmia therapycircuit 715 delivers the antitachyarrhythmia therapy determined by thecontroller circuit 720. In an example, the antitachyarrhythmia therapycircuit includes electrodes that are integrated into a housing of theanalysis/therapy module that carries its electronics.

In other examples, one of the systems shown in FIGS. 1A-7A includes oneor more additional modules. In one example, a system includes a memorymodule including a memory circuit and communication circuit. In anotherexample, a system includes a pacing module including pacing circuitry.In another example, a system includes a respiratory sensing moduleincluding respiratory sensing circuitry. In another example, a systemincludes a respiratory stimulation module including respiratorystimulation circuitry. In another example, a system includes a chemicalsensor module or a chemical or drug delivery module. In an example, asystem includes sensors that detect blood chemistry in the heart or inarteries or other vessels. In an example, a system includes one or moresensors detect oxygen saturation and/or pH levels in blood.

In some examples, certain modules are combined into a system thatincludes at least two separately located modules that wirelesslycommunicate with each other. In an example, pacing circuitry is includedin a defibrillation module or a heart sensing module. In anotherexample, respiration sensing and respiration stimulation are performedby a single module. In another example, chemical sensors or chemicaldelivery mechanisms are included with antitachyarrhythmia therapymodules or other modules.

FIG. 8A shows an example of a modular implantable system 800 thatincludes a variety of separate sensor modules. FIG. 8B is a schematicillustration of the system shown in FIG. 8A that shows schematicillustrations of circuits in the modules. The system 800 includesseparate modules 802, 804, 806, 812, 814, 816. In an example, each ofthe separate modules 802, 804, 806, 812, 814, 816 includes a sensor tosense a physiologic parameter and a wireless transmitter circuit to senda wireless communication that includes information about the physiologicparameter. In another example, two or more of the sense circuits arecoupled to another module with a lead or are combined in a singlemodule. In one example, module 802 includes a sense amplificationcircuit 842 (shown in FIG. 8B) to detect an intrinsic electrical heartsignal and a wireless transmitter circuit 843 that transmits informationabout the intrinsic electrical heart signal. In one example, module 804includes a heart sound sensor 844 to detect a heart sound and a wirelesstransmitter circuit 845 that transmits information about the heartsound. In one example, module 806 includes a respiration sensor 846 anda wireless transmitter circuit 847 that transmits information about therespiration. In one example, module 808 includes a wireless receivercircuit 849 to receive a diaphragmatic pacing instruction and adiaphragm stimulation circuit 848 to deliver a diaphragmatic pacingpulse. In an alternative example, module 806 and 808 are combined in asingle module.

In one example, module 810 includes a pacing stimulation circuit 850 todeliver a pacing pulse and a wireless receiver circuit 851 that receivea pacing instruction. In this example, module 812 includes a bloodpressure sensor 852 to detect blood pressure and a wireless transmittercircuit 853 that transmits information about the blood pressure. In anexample, module 812 is sized and shaped for implantation in the heart,or in vasculature near the heart. In another example, module 812 issized and shaped for implantation in pulmonary vasculature, such as inthe pulmonary vascular bed. In an example system, the pacing stimulationcircuit in module 810 adjusts delivery of a pacing pulse in response toinformation provided from another module, such as information about theblood pressure provided by module 812. In one example, module 814includes an atrial sensing circuit 854 that senses an intrinsicelectrical atrial signal and a wireless communication circuit 855 thattransmits includes information about the atrial signal. In one example,module 816 includes a ventricular sensing circuit 856 that senses anintrinsic electrical ventricular signal, and a wireless transmitter 857that transmits information about the ventricular signal. In someexamples, one or more of modules 802, 804, 806, 812, 814, 816, includecircuitry that processes a signal or data obtained from a physiologicalsensor.

In one example, module 820 includes a wireless receiver or transceivercircuit 821 that receives a wireless communication from one or more ofthe other modules. Module 820 also includes a controller circuit 822that uses the information about one or more physiologic parametersreceived from one or more of the other modules 802, 804, 806, 812, 814,816, such as to provide diagnostic information or to determine therapy.In an example, the controller circuit 822 uses information about theatrial signal received from module 814. In another example, thecontroller circuit 822 uses information about the ventricular signalreceived from module 816. In another example, the controller circuit 822uses information about both the atrial and ventricular signals. In anexample, module 820 also includes an antitachyarrhythmia therapy circuitthat delivers a responsive antitachyarrhythmia therapy. In anotherexample, module 820 includes a wireless transmitter circuit 821 thattransmits a wireless antitachyarrhythmia therapy instruction to module830, which includes a communication circuit 834 and antitachyarrhythmiacircuitry 832 that delivers an antitachyarrhythmia therapy in accordancewith the instruction from module 820. In an example, modules 820 and 830each include an antitachyarrhythmia therapy circuit. In an example,module 820 is implanted subcutaneously and can be replaced withoutreplacing other modules.

In another example, some of the modules 802, 804, 806, 808, 810, 812,814, 816, 820, 830 are combined together in a system that includes atleast two separate modules that wirelessly communicate with each other.In an example, the modules 802, 804, 812 that respectively sense bloodpressure, heart sound, and an intrinsic electrical heart signal arecombined into a single module 803 that includes such sensors and awireless transmitter that transmits information about variousphysiological parameters detected by the sensors.

In an example, the system receives information about physiologicparameters through multiple channels. In one example, the system 800 issenses at least two physiologic parameters concurrently using physicallyseparate modules, and includes a memory circuit that records informationrelating to the at least two physiologic parameters. In an example, thesystem includes stores information about physiologic parameters receivedbefore a tachyarrhythmia in the memory circuit. In an example, thesystem includes an implantable memory circuit that can be replacedwithout replacing other modules.

FIG. 9 is a schematic illustration of an example of anantitachyarrhythmia therapy circuit 900. A pulse generator 905 includesa battery 910 and a pulse circuit 906. In an example, the pulse circuit906 includes a capacitor for building a charge that is deliverable in apulse across the electrodes. The pulse generator 905 receives aninstruction from a controller circuit 925. In an example, the controllercircuit 925 communicates through telemetry circuitry coupled to thepulse generator 905. In another example, the controller circuit 925 isphysically connected to the pulse generator 905. The controller circuit925 instructs the pulse generator 905 to draws power from the batteryand delivers an energy, such as a defibrillation shock, acrosselectrodes 915, 920.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Since many embodiments of theinvention can be made without departing from the spirit and scope of theinvention, the invention resides in the claims hereinafter appended.

1. (canceled)
 2. An implantable cardiac stimulus device for use in apatient having a heart, comprising a housing containing sensingcircuitry and therapy circuitry for providing cardiac stimulus, thehousing adapted for coupling to a lead having at least one electrodethereon; the implantable cardiac stimulus device being configured forimplantation, sensing and therapy delivery from outside the heart, usinga lead also implanted outside the heart; wherein the implantable cardiacstimulus device is configured to communicate, using the patient's bodyas a conductive medium for communication, with a physically separatefirst module adapted for implantation inside the heart of the patient.3. The implantable cardiac stimulus device of claim 2, furtherconfigured to communicate, using the patient's body as a conductivemedium for communication, with a physically separate second moduleadapted for implantation in the patient.
 4. The implantable cardiacstimulus device of claim 3, further configured to receive data relatedto ventricular sensing from the first module and data related to atrialsensing from the second module.
 5. The implantable cardiac stimulusdevice of claim 3, further configured to receive data related to cardiacelectrical activity from the first module and data related to bloodpressure from the second module.
 6. The implantable cardiac stimulusdevice of claim 3, further configured to receive data related to cardiacelectrical activity from the first module and data related to heartsounds from the second module.
 7. The implantable cardiac stimulusdevice of claim 3, further configured to receive data related to cardiacelectrical activity from the first module and data related torespiration from the second module.
 8. The implantable cardiac stimulusdevice of claim 3, further configured to send a message related to anantitachyarrhythmia output to one of the first or second modules.
 9. Theimplantable cardiac stimulus device of claim 2, further configured tosend a message related to an antitachyarrhythmia output to the firstmodule.
 10. An implantable cardiac stimulus system for use in a patienthaving a heart, comprising: a housing containing sensing circuitry andtherapy circuitry for providing cardiac stimulus; a lead having at leastone electrode thereon and configured for coupling to the housing; thehousing and lead being configured for implantation, sensing and therapydelivery from outside the heart; wherein the implantable cardiacstimulus device is further configured to communicate, using thepatient's body as a conductive medium for communication, with aphysically separate first module adapted for implantation inside theheart of the patient.
 11. The implantable cardiac stimulus device ofclaim 10, further configured to communicate, using the patient's body asa conductive medium for communication, with a physically separate secondmodule adapted for implantation in the patient.
 12. The implantablecardiac stimulus device of claim 11, further configured to receive datarelated to ventricular sensing from the first module and data related toatrial sensing from the second module.
 13. The implantable cardiacstimulus device of claim 11, further configured to receive data relatedto cardiac electrical activity from the first module and data related toblood pressure from the second module.
 14. The implantable cardiacstimulus device of claim 11, further configured to receive data relatedto cardiac electrical activity from the first module and data related toheart sounds from the second module.
 15. The implantable cardiacstimulus device of claim 11, further configured to receive data relatedto cardiac electrical activity from the first module and data related torespiration from the second module.
 16. The implantable cardiac stimulusdevice of claim 11, further configured to send a message related to anantitachyarrhythmia output to one of the first or second modules. 17.The implantable cardiac stimulus device of claim 10, further configuredto send a message related to an antitachyarrhythmia output to the firstmodule.
 18. An implantable system comprising: first means for sensingcardiac data and determining whether an arrhythmia requiring therapy isongoing; and second means for delivering anti-arrhythmia therapy andconfigured to communicate with the first means using the body of apatient as a conductive means for communication, wherein the secondmeans is configured to determine, using information communicated by thefirst means, whether and when to deliver anti-arrhythmia therapy;wherein the first means is configured for communication with the secondmeans using the body of the patient as a conductive medium forcommunication to the second means; and wherein at least one of the firstmeans and second means is sized and configured for placement inside theheart of the patient, and the other of the first means and second meansis sized and configured for placement outside the heart of the patient.19. The implantable system of claim 18 wherein the first means isconfigured to detect electrical cardiac signals, the system furthercomprising third means for capturing non-electrical data indicative ofwhether an arrhythmia requiring therapy is ongoing and communicating toat least one of the first means and the second means using the body ofthe patient as a conductive medium for communication.
 20. Theimplantable system of claim 18 wherein the first means is configured forimplantation in the heart of the patient and second means is configuredfor subcutaneous implantation outside of the heart of the patient. 21.The implantable system of claim 18 wherein the second means isconfigured for implantation in the heart of the patient and first meansis configured for subcutaneous implantation outside of the heart of thepatient.